Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Smoking
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Psychological treatment (cognitive-behavioral) is a first-line smoking cessation treatment that has proven its efficacy. However, it is necessary to continue investigating to improve smoking outcomes as abstinence and reduce relapse rates. The use of information technologies (ICTs) in the field of h...

Psychological treatment (cognitive-behavioral) is a first-line smoking cessation treatment that has proven its efficacy. However, it is necessary to continue investigating to improve smoking outcomes as abstinence and reduce relapse rates. The use of information technologies (ICTs) in the field of health has grown and developed significantly in recent years. Specifically, mobile applications (Apps), aimed at different health-related aspects (mHealth Apps), are a valuable resource. Its use, as a complement to the face-to-face treatment, could help to increase motivation to quit smoking, treatment adherence, and therapeutic activities compliance. mHealth Apps are becoming highly relevant due to their cost-effectiveness and the added attractiveness for many users. Considering this context, the main aim of the present project is to design and assess the efficacy of a cognitive-behavioral treatment (CBT) for smoking cessation enriched with a Smartphone App. A randomized clinical trial will be carried out with a sample of 270 treatment-seeking smokers at the Smoking Cessation and Addictive Disorders Unit of the University of Santiago de Compostela. Participants will be randomly assigned to one of the following groups: The experimental group (CBT + App), in which participants will receive a cognitive-behavioral treatment* to quit smoking along with an App with active therapeutic components during the treatment and 12 months follow-ups period (n = 135) The control group (CBT), in which participants will receive the same cognitive-behavioral treatment* along with the use of a Control App (without active components) during the treatment (n = 135). The main hypothesis is that the combination of a cognitive-behavioral psychological treatment to quit smoking and an App with active therapeutic components will obtain higher abstinence rates at the end of treatment and the 12-month follow-up period, compared to the control group * Due to the COVID-19, the face-to-face cognitive-behavioral treatment will be conducted in an online format

Tracking Information

NCT #
NCT04765813
Collaborators
Ministerio de Ciencia e Innovación, Spain
Investigators
Principal Investigator: Elisardo Becoña, PhD University of Santiago de Compostela